SoCCs
Research type
Research Study
Full title
UK Real World Study of Amgevita in Crohn’s Disease (CD) and Ulcerative Colitis (UC)
IRAS ID
268364
Contact name
Fraser Cummings
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
We are proposing to conduct a ‘real world’ phase IV, prospective, multi-centre observational study. Our primary objective is to understand the real-world experience of patients diagnosed with either Crohn’s Disease (CD) or Ulcerative Colitis (UC) and are receiving Amgevita.
As the primary objective of the study is to compare real-world experiences, we have tried to mirror patient’s pathway of receiving Amgevita and have included two cohorts. We aim to recruit 500 patients who will transition from Humira (adalimumab) to Amgevita and 200 patients will be starting Amgevita.
The secondary objectives are:
1) To find new methods for collecting patient data.
2) How well patients tolerate Amgevita and the drugs safety.
3) How effective Amgevita is on disease activity measured through questionnaires and looking at blood and stool samples (if available as Standard of Care)
4) To understand patients, experience whilst taking Amgevita measure through a Treatment Satisfaction Questionnaire.
As Amgevita is already a licensed drug for the patient group, we will not change the patient’s normal pathway and all data will be collected through normal clinic visits. We will ask patients to complete questionnaires at home before they administer Amgevita. We will ask patients to use an app to complete the questionnaires at home. Training will be provided by the research team at the baseline visit.
We aim to have this study open at several sites across the NHS with each site having a Principal Investigator and research team.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0732
Date of REC Opinion
8 Jan 2020
REC opinion
Further Information Favourable Opinion